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EC number: 618-347-7
CAS number: 9003-01-4
SIPOMER B-CEA was
tested for primary dermal irritation/corrosion in 3 New Zealand White
rabbits. Each of the 3 rabbits received three 0.5 ml doses of the test
article (a liquid) on a dry compress in a single dermal dose to 2.5 cm2clipped
area of the skin. The doses were held in contact with the skin under a
semi-occlusive patch for an exposure period of 3 minutes, 1 hour, and
4-hours, respectively. Cutaneous examinations were performed at removal
of the dressing, after wiping of the remaining test article, then daily
for up to 14 days.
Exposure for 3 minutes
produced very slight erythema (score 1) in 2/3 animals at removal of the
dressing. The effects resolved completely by the 24-hour observation
time. No oedema was observed.
Exposure for 1 hour
produced very slight erythema (score 1) in all 3 animals at removal of
the dressing. On one site, erythema increased to well-defined (grade 2)
at 72 hours. The effects resolved completely by day 7 (2/3 animals) or
day 10 (1 animal). No oedema was observed.
Exposure for 4 hours
produced very slight erythema (score 1), and very slight (2/3 animals)
to well-defined oedema (1 animal). Oedema resolved completely by the
72-hour observation time. On 3 test sites, the erythema increased to
well-defined by the 72-hour scoring and persisted at day 7 on one site.
Additional findings included superficial lightening and desquamation on
3 sites and 1 site, respectively. These effects resolved completely by
day 14. The individual mean scores for each animal were 1.33 – 1.33 –
1.33 for erythema, and 0.33 – 0.67 – 0.33 for oedema. (or PII: 1.92)
Based on these results,
SIPOMER B-CEA should not be classified as a skin irritant according to
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